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Preoperative Breathing Exercise Training and Postoperative Delirium After Robotic Radical Prostatectomy

NCT07766603 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-14

No results posted yet for this study

Summary

Postoperative delirium is an acute and fluctuating disturbance in attention, awareness, and thinking that may occur after major surgery. Patients undergoing robot-assisted radical prostatectomy may be at risk because of factors such as older age, general anesthesia, prolonged surgery, pneumoperitoneum, and steep Trendelenburg positioning.

This single-center, prospective, two-arm controlled pilot study will evaluate whether preoperative deep breathing exercise training is associated with a lower occurrence of postoperative delirium in patients undergoing elective robot-assisted radical prostatectomy. A total of 50 patients will be included, with 25 patients in the breathing exercise training group and 25 patients in the control group.

Patients in the breathing exercise training group will receive standardized, device-free deep breathing exercise instruction during the preoperative period, usually approximately one week before surgery. They will be asked to perform three sessions per day until surgery, with 10 deep breaths in each session. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training.

Postoperative delirium will be assessed during the first 48 hours after surgery using the 4AT and Nursing Delirium Screening Scale (Nu-DESC). The study will also evaluate postoperative oxygenation, oxygen requirement, pain, nausea and vomiting, respiratory complications, intensive care requirement, and length of hospital stay. The study will not alter routine anesthesia, surgery, or postoperative treatment, and no additional invasive procedures, laboratory tests, or imaging will be performed for research purposes.

Conditions

Interventions

BEHAVIORAL

Preoperative Deep Breathing Exercise Training

Participants will receive standardized, device-free deep breathing exercise training during the preoperative period. In an upright or semi-upright position, participants will be instructed to relax their shoulders, inhale slowly and deeply through the nose, hold their breath for approximately 2-3 seconds, and then exhale slowly through the mouth. Each session will consist of 10 deep breaths. Participants will be asked to perform three sessions per day from the time of training until surgery. Exercise adherence will be documented using a home follow-up form and reviewed on the morning of surgery.

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • ALİ DEMİRTAŞ

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-07-31
Completion
2027-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766603 on ClinicalTrials.gov